"Since BioPort is the only licensed manufacturer of the anthrax vaccine, today's approval is especially important," said Health and Human Services Secretary Tommy G. Thompson.
"This vaccine meets FDA's high standards for safety and efficacy. FDA is also allowing three lots of the vaccine manufactured in the renovated facility to be released today, after thorough testing and review," he said.
Although the Centers for Disease Control and Prevention in Atlanta does not recommend vaccination for the general public, this product is a critical component in the U.S. arsenal against bioterrorism, Thompson said at a news conference in Washington.
He added that the federal government is aggressively supporting efforts to develop new vaccines and diagnostic tools for the disease agents most likely to be used in a bioterrorism attack.
"In particular, the National Institutes of Health is moving rapidly in developing a possible new-generation anthrax vaccine," Thompson said. "As with the existing vaccine, NIH efforts are subject to the rigorous safety and effectiveness standards of the FDA."
Bioport's President Robert Kramer said last fall, when anthrax letters were sent through the U.S. Postal Service, resulting in five deaths, the company was "waiting on FDA approval of the facility, not on the product itself."
"Our lab was previously owned and operated by the state of Michigan and had a 70-year history of providing vaccines for Michigan and elsewhere," Kramer said.
In 1995, Michigan decided it no longer needed the means to provide vaccines for its citizens, and after enabling legislation was approved, its labs were put up for sale and acquired by Bioport.
Robert C. Myers, Bioport's chief scientific officer, said the aging facilities, with some infrastructure dating back to the 1920s, required constant attention and frequent renovation, both time-consuming and costly.
The renovated laboratory repeatedly failed to pass FDA inspections because of contamination, inadequate record-keeping and procedures that did not meet manufacturing specifications.
Before the anthrax attacks last fall, the vaccine was used to protect veterinarians and scientists working with anthrax. The anthrax vaccine was first developed in 1965 by the Biologic Products Division of the Michigan Department of Public Health and has been licensed for 30 years, according to BioPort.
Eleven years ago, Bioport manufactured large amounts of the anthrax vaccine for the military, which now owns all stored supplies, for use among troops in the Persian Gulf. Since then, there have been allegations the vaccine may have contributed to "Gulf War Syndrome" and only 20 percent of the U.S. military has been vaccinated.
"We've had at least 54 calls from (military) veterans or family members who said they have been injured from taking the vaccine," New York Metro Postal Union president William Smith told United Press International on Jan. 4. "It's outrageous," he said.
In December, federal officials made the anthrax vaccine available to those exposed to large amounts of anthrax, including postal workers and congressional staff members from offices where anthrax letters were opened. The Postal Service, as well as the District of Columbia, refused to recommend the vaccine to those eligible to receive it, however, because of the risk of side effects.
Since then, fewer than 150 postal workers and fewer than 75 congressional staffers -- out of 3,000 people considered eligible -- have taken the three-dose vaccine.
Kramer said the vaccine is "absolutely safe" and noted that more than 13 independent studies have been performed on it to prove safety.